Medical Device Manufacturer · US , Salt Lake City , UT

Ultradent Products, Inc.

102 submissions · 102 cleared · Since 1992
102
Total
102
Cleared
0
Denied

Ultradent Products, Inc. — FDA 510(k) Submissions

Ultradent Products, Inc. has submitted 102 FDA 510(k) premarket notifications since 1992, of which 102 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Agent, Tooth Bonding, Resin, Material, Tooth Shade, Resin, Cement, Dental, Varnish, Cavity, Sealant, Pit And Fissure, And Conditioner . Use the specialty filter in the sidebar to narrow results.

102 devices
1–25 of 102
Peak Universal Bond
K240743 · KLE Agent, Tooth Bonding, Resin · Dental
Mar 2024 2d
FORMA Composite (Shade A3D)
K240694 · EBF Material, Tooth Shade, Resin · Dental
Mar 2024 1d
J-Temp
K221909 · EBF Material, Tooth Shade, Resin · Dental
Jul 2022 1d
VALO X, VALO X Accessory Lenses
K220471 · EBZ Activator, Ultraviolet,... · Dental
Feb 2022 4d
UltraCal XS
K211905 · KIF Resin, Root Canal Filling · Dental
Oct 2021 114d
UltraTemp Rez II
K211237 · EMA Cement, Dental · Dental
Jul 2021 78d
VALO Grand Corded and Accessory Lenses
K210550 · EBZ Activator, Ultraviolet,... · Dental
Mar 2021 4d
VALO Grand Corded
K190627 · EBZ Activator, Ultraviolet,... · Dental
Apr 2019 48d
ChlorCid, ChlorCid V, ChlorCid Surf
K173163 · KJJ Cleanser, Root Canal · Dental
Feb 2018 133d
VALO Grand
K160551 · EBZ Activator, Ultraviolet,... · Dental
Jul 2016 135d
Astringedent Clear
K152064 · MVL Cord, Retraction · Dental
Sep 2015 62d
Mosaic Universal Composite
K151094 · EBF Material, Tooth Shade, Resin · Dental
Jul 2015 89d
PEAK Z
K131357 · KLE Agent, Tooth Bonding, Resin · Dental
Sep 2013 119d
VISCOSTAT CLEAR
K123215 · MVL Cord, Retraction · Dental
Feb 2013 113d
ULTRASEAL XT HYDRO
K112517 · EBC Sealant, Pit And Fissure,... · Dental
Sep 2011 23d
PERMASHADE VENEER CEMENT
K111836 · EMA Cement, Dental · Dental
Sep 2011 79d
OPAL BAND CEMENT
K111696 · DYH Adhesive, Bracket And... · Dental
Sep 2011 82d
CLEARTEMP
K111017 · EMA Cement, Dental · Dental
Jun 2011 55d
VALO CORDLESS
K110582 · EBZ Activator, Ultraviolet,... · Dental
Apr 2011 58d
ULTRASEAL ID
K101245 · EBC Sealant, Pit And Fissure,... · Dental
Sep 2010 136d
PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)
K100752 · KLE Agent, Tooth Bonding, Resin · Dental
Jul 2010 121d
OPAL BOND FLOW
K100301 · DYH Adhesive, Bracket And... · Dental
Apr 2010 85d
OPAL BOND MV
K094006 · DYH Adhesive, Bracket And... · Dental
Mar 2010 85d
OPAL SEAL
K090355 · DYH Adhesive, Bracket And... · Dental
Apr 2009 77d
VALO, MODEL 5919
K083647 · EBZ Activator, Ultraviolet,... · Dental
Jan 2009 45d

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